On the 16th of December, the European Medicines Agency (EMA) published the updated version of the critical medicines list (CML), marking a significant step in securing the supply of essential medicines in the EU, to treat allergy and respiratory diseases among others.
The list identifies medicines deemed critical based on two criteria: those whose insufficient supply could result in serious harm to patients and who have also been on shortage. The list now includes 288 medicines, an increase of 28 compared to the first version. Among all the critical medicines, the list includes five key respiratory treatments, addressing conditions such as asthma and COPD.
What are the critical allergy and respiratory medicines for the EU?
The following five respiratory medicines, previously listed in the first version of the list, remain critical for patients with airways diseases:
- Salbutamol: A bronchodilator that opens the lungs and is used for asthma and COPD (short-acting β2 adrenergic receptor agonist). The inhalation products with salbutamol are in shortage in most EU/EEA countries and shortages persist due to increased usage and manufacturing issues.
- Ephedrine: An essential for acute bronchospasm (alfa and beta adrenergic receptor agonist). No current shortages reported.
- Ipratropium: An inhaled bronchodilator for asthma and COPD (anticholinergic medication). While specific products face shortages (e.g., albuterol sulfate and ipratropium bromide inhalation solutions by Cipla), alternatives remain available.
- Methylprednisolone: A corticosteroid for allergic rhinitis and asthma. Shortages are noted for methylprednisolone sodium succinate powder for injection but other options are available.
- Acetylcysteine: An expectorant aiding the elimination of lung secretions, for example in episodes of acute pneumonia and bronchitis. Intravenous formulations face no shortages, although some oral and inhalation solutions are limited, but many other products available.
- Epinephrine: cardiac stimulant used for anaphylaxis due to severe allergic reactions (anaphylaxis) resulting from food allergens, insect bites, respiratory allergens and other allergens. There are remaining and frequent shortages for epinephrine autoinjectors but other autoinjector remain available.
- In addition to these critical medicines, the list includes antibiotics, antifungals and vaccines crucial for combating respiratory diseases like pneumonia, influenza, diphtheria and severe fungal infections like aspergillosis.
Medicines for allergy and dermatology not considered critical
As representative of patients with allergy, atopic eczema and airways diseases, EFA actively participated in the stakeholder consultation for the review of the Critical Medicines List in May 2024. However, the EU Member States and Norway decided not to include our suggestions to the list, like the addition of antihistamines as front like treatment against allergic reactions.
One of the reasons not to include them provided by the EMA is that the market supply for EFA disease areas such as allergy and atopic dermatitis is rather good and not facing major EU cross-border disruptions.
Future areas for improvement
EFA welcomes the second version of the Critical Medicines List as a tool to safeguard the supply of essential medicines in the EU. We are encouraged that our response raised awareness among Member States and call on them to promptly report shortages at the national level to the EMA.
We remain a source of information to Member States and the EMA, looking forward to advance on two points that have not been included in the methodology of the list yet.
Seasonal reflection: shortages often worsen in winter, when bronchodilators are in higher demand, prescribed to patients infected with respiratory viruses. EFA calls for seasonality to be considered by EU and Member States when stockpiling for critical allergy and respiratory medicines.
Focus on children: children face a higher risk of medicine shortages due to limited age-appropriate formulations. Greater attention to pediatric needs can reduce reliance on off-label use of medicines among children, and enhance safety.
Looking ahead, EFA will monitor the implementation of the Critical Medicines Act, including joint procurement and stockpiling. These measures are expected to take shape during the next European Commission mandate.